Plain English Summary

Background and study aimsWhen a person is in hospital for an operation, they often spend a lot of time in bed, putting them at risk of deep vein thrombosis (DVT). DVT is where a blood clot develops in a deep vein in one or both of the legs, causing pain, swelling and long term complications such as leg ulcers. If a DVT is not treated, then there is a risk that part of the blood clot could break off and become stuck in one of the lungs, blocking blood supply (pulmonary embolism, PE). Together, these two conditions are known as venous thromboembolism (VTE), which is a leading cause of death and disability worldwide. The importance to preventing patients from developing VTE is widely recognized. The main strategies in place involve anticoagulant medications (which thin the blood so it cannot form the harmful clots) and mechanical devices such as elasticated compression stockings (which apply continuous pressure to the legs, helping to maintain bloodflow). Evidence for using elastic stockings to prevent VTE has been challenged, with a lack of evidence for the additional benefits of elastic stockings over and above the benefit of blood-thinning. If elastic stockings reduce VTE over and above blood thinners, these benefits need to be weighed against the disadvantages, such as discomfort, restricting blood flow to the leg, blistering, cost and staff needing to help patients to put them on. The aim of this study is to look at whether patients who wear elastic stockings as well as taking anticoagulant medication have a lower chance of developing VTE than patients who take anticoagulant medications only.

Who can participate?Adults who are having surgery at a participating hospital, who are at risk of developing VTE.

What does the study involve?Participants are randomly allocated to one of two groups. Those in the first group are given graduated compression stockings (specially designed compression stockings where the pressure is at the highest level around the ankle and becomes lower further up the leg) to wear during their hospital stay, as well as taking low molecular weight heparin (anticoagulant medication especially for treating VTE), the dosage of this is determined by each patients' individual characteristics. Participants in the second group take low molecular weight heparin only. Participants attend follow up appointments after 1 and 2-3 weeks, as well as 90 days after surgery, to have their legs scanned to check for the presence of any blood clots. Participants also complete a number of questionnaires in order to find out if their quality of life has improved.

What are the possible benefits and risks of participating?There are no direct benefits of taking part as the treatments given (i.e. heparin plus stockings) are already provided in standard care. Participants benefit from receiving a scan for the presence of DVT in this study and so are able to receive treatment. There are no significant risks of taking part, however some participants may experience some side-effects from the medication or may find the compression stockings uncomfortable at first as they are very tight.

Where is the study run from?At least seven NHS hospitals in England (UK)

When is the study starting and how long is it expected to run for?December 2015 to November 2018

Trial website

Contact information

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ORCID ID

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EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20354

Study information

Scientific title

Examining the benefit of graduated compression stockings as an adjunct to low dose low molecular weight heparin in the prevention of venous thromboembolism in elective surgical inpatients identified as moderate or high risk for venous thromboembolism: A multi-centre randomised controlled trial

Acronym

GAPS

Study hypothesis

The aim of this study is to investigate whether treatment with elastic compression stockings and blood thinning medicines combined are more effective at preventing venous thromboembolism (VTE) than blood­thinning medicines alone.

Study design

Primary study design

Secondary study design

Trial setting

Trial type

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Surgery; Subtopic: Surgery; Disease: All Surgery

Intervention

Participants are randomly allocated using a computer to one of two groups.

Group 1: Participants are treated with low molecular weight heparin (LMWH) as per standard clinical recommendations (dosing regimen depending on participant characteristics). These patients are also given either below- or above-knee graduated compression stockings (GCS) to wear as per advice of the treating clinician.

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Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Planned publication and presentation of results at scientific meetings2. Summaries of results will also be made available to Investigators for dissemination within their clinical areas (where appropriate and according to their discretion)3. There will also be an online dissemination plan, with participants and healthcare professionals able to access results on a trial website, and appropriate use of social media (Twitter, Facebook, LinkedIn)4. Trial participants will also be offered a mailed summary of the trial findings